Posts tagged ‘ISO’

A common finding when auditing is discovering that the organisation or department that you are auditing is not following their own internal procedure or policy. This is a non-conformity, and should be raised as such. The problem is – what clause of the standard actually states that you should follow your procedures? On investigation this is not as easy to find as you might like to think!Read more

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In many standards that exist there are often statements such as “there must be a procedure to control training records”. Whilst I am sure that none of you will disagree with a statement such as this there is an element of unclarity in the statement itself. It surrounds the use of the word “procedure“ and what is meant by a procedure.Read more

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The ISO 9001 standard is the international standard for Quality Management Systems. During its review in the late 1990 they removed its “obsession” of needing a documented procedure to cover most tasks. This is because organisations vary in size and complexity, and it may not be necessary to control an activity via an approved procedure. There are many things that we do in life every day that are not subject to a formal procedure, yet we do them without any problems.

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I perform a number of audits throughout the year. Most are supplier audits but some are internal audits. In order to make the audits as efficient as possible I recommend good planning for the audit – rather than just turning up on the day and “going with the flow”.

Firstly – make contact with your host (auditee) well before the audit. This starts the communication process with them. During this time you can discuss (via telephone or email) any domestic arrangements, such as site location, local hotel, times and dates, etc. From these early discussion an audit programme should be produced and sent to the auditee at least 2 weeks beforehand. This allows them to understand where you are likely to go during the audit.

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A lot has been said about ISO 9001 in the pharmaceutical industry. This article tries to compare the two fairly. You should read Part 1 first to get some idea of the differences. One of the main problems of comparing GMP and ISO is that the two standards are not the same and are not really trying to do the same thing. GMP is a product quality standard, with a focus on getting the right quality product to the only customer of GMP – the patient. ISO 9001 on the other hand is more about running a whole business, a goal of which will be getting product of the right quality – but other aims are important too. Whilst GMP focuses on Production and Quality Control – ISO focuses on the all departments and processes of an organisation. NOTE – THIS ARTICLE WAS WRITTEN BEFORE RECENT UPDATES TO EU GMP CHAPTERS 1 AND 2 AND SO HAS SOME ASPECTS THAT ARE NOW OUT OF DATE.